FDA product code DWD: Suction Control, Intracardiac, Cardiopulmonary Bypass
DWD is the FDA product code for suction control, intracardiac, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4430 and reviewed by the Cardiovascular panel. FDA has cleared 15 510(k) submissions under DWD, from 11 different applicants. The average 510(k) review took 106 days (median 53).
Classification
| Field | Value |
|---|---|
| Device name | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4430 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DWD clearance
Top DWD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1992-01-07 |
| American Omni Medical, Inc. | 3 | 1987-01-06 |
| International Biophysics Corp. | 1 | 2000-02-18 |
| International Medical Products, Inc. | 1 | 1993-09-29 |
| Baxter Bentley Laboratories, Inc. | 1 | 1991-01-15 |
6 more applicants have DWD clearances. See the full list in Caduvo.
Most recent DWD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992657 | International Biophysics Corp. | IBC VRV, MODEL 1350 | 2000-02-18 | 193 |
| K920077 | International Medical Products, Inc. | NIKKISO NK PUMP | 1993-09-29 | 630 |
| K915481 | Bd Becton Dickinson Vacutainer Systems Preanalytic | B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT | 1992-01-07 | 32 |
| K915482 | Bd Becton Dickinson Vacutainer Systems Preanalytic | B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT | 1992-01-07 | 32 |
| K915480 | Bd Becton Dickinson Vacutainer Systems Preanalytic | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. | 1992-01-07 | 32 |
Recalls for DWD devices
openFDA lists no recalls for product code DWD.
Frequently asked questions
What is FDA product code DWD?
DWD is the FDA product code for suction control, intracardiac, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4430 and reviewed by the Cardiovascular panel.
What device class is DWD?
Class II, regulation 21 CFR 870.4430. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DWD?
Across 15 cleared submissions the average was 106 days from receipt to decision (median 53).
Which companies have the most DWD clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (3); American Omni Medical, Inc. (3); International Biophysics Corp. (1); International Medical Products, Inc. (1); Baxter Bentley Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DWD
- Run a recall and safety report across every DWD manufacturer
- Watch product code DWD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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